
[Federal Register Volume 80, Number 80 (Monday, April 27, 2015)]
[Notices]
[Pages 23279-23280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09646]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1309]


M8 Electronic Common Technical Document v4.0 Draft Implementation 
Guide v2.0; Electronic Common Technical Document v4.0 Implementation 
Package Draft Specification for Submission Formats v2.0; International 
Conference on Harmonisation; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance entitled ``M8 Electronic Common 
Technical Document (eCTD) v4.0 Draft Implementation Guide v2.0'' (the 
M8 eCTD draft implementation guidance) and a related document entitled 
``eCTD v4.0 Implementation Package Draft Specification for Submission 
Formats v2.0'' (the draft specifications document). The M8 eCTD draft 
implementation guidance and the draft specifications document were 
prepared under the auspices of the International Conference on 
Harmonisation (ICH) of Technical Requirements for Registration of 
Pharmaceuticals for Human Use. The M8 eCTD draft implementation 
guidance provides instructions for creating the eCTD v4.0 Health Level 
7 Regulated Product Submission (RPS) message for Modules 2 through 5 of 
the eCTD. The draft specifications document provides specifications for 
creating files for inclusion in the eCTD. These draft documents 
represent major updates to the eCTD specifications.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115 (g)(5)), to ensure that the Agency considers your comment on 
these draft documents before it begins work on the final versions of 
the documents, submit either electronic or written comments on the 
draft documents by May 27, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
documents to the Division of Drug Information (HFD-240), Center for 
Drug Evaluation and Research (CDER), Food and Drug Administration, 
10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver 
Spring, MD 20993-0002; or the Office of Communication, Outreach and 
Development, Center for Biologics Evaluation and Research (CBER), Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 3128, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist the office in processing your requests. The draft documents may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-
7800. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance documents.
    Submit electronic comments on the draft documents to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Jared Lantzy, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 22, Rm. 1116, Silver Spring, MD 20993-
0002, 301-796-0597; or Mark Gray, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7217, Silver Spring, MD 20993-0002, 301-796-2081.
    Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and 
Research, International Programs, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, Rm. 1174, Silver Spring, MD 20993-0002, 
301-796-8377.

SUPPLEMENTARY INFORMATION: 

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of regulatory requirements. FDA has 
participated in many meetings designed to enhance harmonization and is 
committed to seeking scientifically based harmonized technical 
procedures for pharmaceutical development. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input

[[Page 23280]]

from both regulatory and industry representatives. FDA also seeks input 
from consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and the United States. The eight ICH sponsors are the European 
Commission; the European Federation of Pharmaceutical Industries 
Associations; the Japanese Ministry of Health, Labour, and Welfare; the 
Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; 
the Pharmaceutical Research and Manufacturers of America; Health 
Canada; and Swissmedic. The ICH Secretariat, which coordinates the 
preparation of documentation, is provided by the International 
Federation of Pharmaceutical Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization and the European Free Trade Area.
    The eCTD is an ICH standard based on specifications developed by 
ICH and its member parties. The ICH M2 Expert Working Group has 
previously developed a list of requirements for input in the eCTD RPS 
Project. The list of requirements was last updated on November 11, 
2010, and is available at http://estri.ich.org/ICH_eCTD_NMV_Requirements-V4-0.pdf (FDA has verified the Web site 
address, but FDA is not responsible for any subsequent changes to the 
Web site after this document publishes in the Federal Register).
    The ICH M8 Expert Working Group was formed in November 2010 to 
assume responsibility for the continued development of the next major 
version of the eCTD.
    In February 2015, the ICH Steering Committee agreed that a draft 
guidance entitled ``M8 eCTD v4.0 Draft Implementation Guide v2.0'' and 
the related document entitled ``eCTD v4.0 Implementation Package Draft 
Specification for Submission Formats v2.0'' should be made available 
for public comment. These documents are the product of the M8 Expert 
Working Group. Comments about these draft documents will be considered 
by FDA and the M8 Expert Working Group.
    Since adoption of the eCTD standard, the ICH Steering Committee has 
endorsed using the RPS Release 2 standard. A core feature of the RPS 
standard is the flexibility the message provides to enable future eCTD 
enhancements. The M8 eCTD draft implementation guidance provides 
instructions for creating the eCTD v4.0 RPS message for the ICH Modules 
2 through 5 of the eCTD. The draft specifications document provides 
specifications for creating files for inclusion in the eCTD. These 
draft documents facilitate implementation of the eCTD v4.0 standard. 
The draft documents are being issued as a package that includes the 
draft ICH code list and the M8 schema files. In addition, the FDA 
regional/module 1 documents have been developed and are available at 
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm309911.htm.
    The M8 eCTD draft implementation guidance is being issued 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The draft guidance, when finalized, will represent the current 
thinking of FDA on this topic. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
these documents to http://www.regulations.gov or written comments to 
the Division of Dockets Management (see ADDRESSES). It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: April 21, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-09646 Filed 4-24-15; 8:45 am]
 BILLING CODE 4164-01-P


